METHADONE FOR THE TREATMENT OF CHRONIC PAIN CANCER

Phase 1

Completed

• Conditions: -R521 Chronic intractable pain; Chronic intractable pain; R521

• Registration Number: PER-010-99
• Lead Sponsor: DROGERIA MARFAN S.A.C.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 1999-09-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patient diagnosed with cancer confirmed by histology
2. Age between 18 and 70 years.
3. Presence of a pain lasting more than 30 days.
4. Pain secondary to cancer or its treatment.
5. Somatic, visceral, neuropathic or mixed pain
6. Intensity of pain of moderate, intense or very intense degree
7. Kamofsky equal to or greater than 60.
8. Patients who have used the 1st and 2nd therapeutic steps of the WHO require the use of a strong opioid.
9. Patients who accept and can sign an informed consent.
10. Patients who can read, write and do not have cognitive impairment.
11. Patients able to keep a diary during their participation in the study.

Exclusion Criteria

1. Presence of a pain maintained by the sympathetic. The presence of a pain maintained by the sympathetic is suspected when there is a severe pain, burning-like, associated with allodynia (pain secondary to innocuous stimulation in normal skin), hyperpathy (presence of pain after a stimulus is finished), changes trophic skin and its annexes, hard edema and osteoporosis.
2. Vital functions (blood pressure, heart rate and respiratory rate unstable or abnormal.
3. Pregnant or lactating patient.
4. Presence of liver, kidney or respiratory failure, asthma, chronic obstructive pulmonary disease, intracranial hypertension or a history of paralytic ileus.
5. Allergy to morphine or other opioids.
6. Patients scheduled for surgery, chemotherapy, radiotherapy or hormonotherapy during the study period.
7. Patients who received chemotherapy or radiotherapy, or change in the hormonal regimen in the 14 days prior to the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified